Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)

Study Description

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Brief Summary:

The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.

Condition or disease	Intervention/treatment	Phase
Postherpetic Neuralgia; Pain	Drug: V116517 50-mg tablets; Drug: V116517 30-mg tablets; Drug: Pregabalin capsules; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	105 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
Study Start Date :	September 2012
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	April 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: V116517 - 50 mg; V116517 50-mg tablets	Drug: V116517 50-mg tablets; Taken orally twice daily Drug: Placebo; Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Experimental: V116517 - 30 mg; V116517 30-mg tablets	Drug: V116517 30-mg tablets; Taken orally twice daily Drug: Placebo; Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Active Comparator: Pregabalin; Pregabalin capsules	Drug: Pregabalin capsules; 1-2 capsules taken orally twice daily Drug: Placebo; Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Placebo Comparator: Placebo; Placebo	Drug: Placebo; Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily

Outcome Measures

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Primary Outcome Measures :

1. "Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF) [ Time Frame: Week 4 ]

Secondary Outcome Measures :

1. mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6) [ Time Frame: Week 4 ]
2. Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 4 ]
3. Patient Global Impression of Change (PGIC) [ Time Frame: Week 4 ]
4. Supplemental Analgesic Medication Use [ Time Frame: Over 4 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

1. Subjects with chronic pain due to PHN as their primary pain condition and some degree of pain every day from this condition.
2. Clinical diagnosis of PHN based on history of painful dermatomal blistering rash resolving in a few weeks followed by persistent pain in the same region of ≥ 3 months duration.

Key Exclusion Criteria:

1. Subjects with chronic pain conditions other than PHN as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
2. Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
3. Subjects with a recent history of seizure within the past 5 years.
4. Subjects who use opioids more than 4 days per week.
5. Subjects with clinically unstable medical conditions, including cardiac disease (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia); respiratory disease; biliary tract disease; hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study.
6. Subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (PI) to be at serious risk of suicide.

7. PHN-pain-condition-specific exclusions:

   • Subjects who received pain-control interventions including neurolytic blocks or neurosurgical procedures to the affected nerve or spinal cord segment, spinal cord, stimulators, or neuraxial infusion pumps.

8. Active-comparator-related exclusions:

   • Subjects who are allergic to or cannot tolerate pregabalin or acetaminophen.

Other protocol specific inclusion/exclusion criteria may apply.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 28 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

More Information

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Responsible Party:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT01688947 History of Changes
Other Study ID Numbers:	VND2002
First Posted:	September 20, 2012
Last Update Posted:	May 12, 2014
Last Verified:	May 2014

Keywords provided by Purdue Pharma LP:

Pain; Neuralgia, Postherpetic

Additional relevant MeSH terms:

Chronic Pain; Neuralgia; Neuralgia, Postherpetic; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Analgesics; Pregabalin	Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs